Method of treating erectile dysfunction

ABSTRACT

A surgical method of treating erectile dysfunction includes implanting a penile prosthetic in a patient. The penile prosthetic includes an inflatable portion implantable into a penis that is attachable to a liquid reservoir, a pump, and a deflation assembly. The method includes implanting the deflation assembly in contact with an exterior surface of a pelvis of the patient, and positioning an activation surface of the deflation assembly away from the exterior surface of the pelvis. The method thus allows the patient to palpate the activation surface through skin.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes one or more cylinders that areimplanted in the corpora cavernosa of the penis, a reservoir implantedin the abdomen that communicates with the cylinder(s), and a pumplocated in the scrotum that is employed to move liquid from thereservoir into the cylinder(s).

In a typical application, the user squeezes a bulb of the pump multipletimes to draw liquid out of the reservoir, into the bulb, and move theliquid into the cylinders. The repeated squeezing of the bulb moves theliquid from the reservoir into the cylinders, which incrementallydeflates the reservoir and incrementally inflates the cylinder(s) toeventually provide the user with an erect penis. The user may return thepenis to its flaccid state by activating a release mechanism associatedwith the pump to selectively transfer the liquid from the cylinder(s)back into the reservoir.

The above-described penile prosthetics have proven effective inrelieving erectile dysfunction in men. However, there is a desire forimproved penile prosthetic devices.

SUMMARY

One aspect provides a penile prosthetic that includes a cylinder, areservoir, a pump, and a deflation assembly. The cylinder is implantablein a corpora cavernosum. The pump is attachable between the cylinder andthe reservoir and is operable to move fluid from the reservoir toinflate the cylinder. The deflation assembly is attachable between thepump and the reservoir and includes a valve that selectively restrictsmovement of the fluid from the cylinder to the reservoir, a base and anactivation surface opposite the base, where the activation surfaceincludes an outer peripheral rim surrounding a pad that is movable todisplace the valve to allow the fluid to flow from the cylinder to thereservoir. An entirety of the pad is recessed relative to the outerperipheral rim such that the outer peripheral rim defines a maxima ofthe activation surface.

One aspect provides a method of implanting a medical device thatincludes implanting an inflatable penile prosthetic into a penis of apatient, coupling the penile prosthetic to a reservoir, a pump, and adeflation assembly, where the deflation assembly is separate from thereservoir and separate from the pump. The method additionally includesimplanting the deflation assembly between transversalis fascia and anexterior surface of a pelvis of the patient. The deflation assemblyincludes a palpatable activation surface.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of a penile prostheticincluding a reservoir, a pump, and a deflation assembly separate fromthe reservoir and the pump.

FIG. 2 is a perspective view of one embodiment of the deflation assemblyillustrated in FIG. 1.

FIG. 3 is a side view of the deflation assembly illustrated in FIG. 2.

FIG. 4 is an end view of the deflation assembly illustrated in FIG. 2.

FIG. 5 is a cross-sectional view of one embodiment of the deflationassembly illustrated in FIG. 3.

FIG. 6 is a schematic view of one embodiment of the penile prostheticillustrated in FIG. 1 implanted in a man.

FIG. 7 is a front view of a pelvis showing the deflation assemblyillustrated in FIG. 1 implanted against an iliac fossa of the pelvis.

FIG. 8 is a side view of a pelvis showing the deflation assemblyillustrated in FIG. 1 implanted against an iliac crest of the pelvis.

FIG. 9 is a top view of a pelvis showing the deflation assemblyillustrated in FIG. 1 implanted between transversalis fascia and anexterior surface of the pelvis.

FIG. 10A is a cross-sectional view of one embodiment of a penileprosthetic deflation assembly.

FIG. 10B is a cross-sectional view of one embodiment of a valve assemblyof the deflation assembly illustrated in FIG. 10A.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” as employed in this application means that thereferenced part is situated next to or near the point of attachment ororigin or a central point: as located toward a center of the human body.The term “distal” as employed in this application means that thereferenced part is situated away from the point of attachment or originor the central point: as located away from the center of the human body.A distal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. Forexample, the glans penis is located distal, and of the crus of the penisis located proximal relative to the male body such that a distal end ofa corpora cavernosum of the patient extends about midway into the glanspenis.

“Fluid” means a non-solid substance that flows and includes gases andliquids, or a combination of a gas and a liquid.

“Gas” means a substance having molecules that disperse and are free toexpand to occupy an entire volume of a container in which it isdisposed. Air and methyl butane are two examples of gases.

“Liquid” means a substance having molecules that do not disperse suchthat the liquid resists compression and the molecules of the liquid willnot disperse to fill all spaces of a container in which the liquid isdisposed. Saline is an example of a liquid.

“Maxima” means the point that is a maximum distance away from a surface.In this specification, a deflation assembly provides an activationsurface that includes an outer peripheral rim surrounding an activationarea, and the activation area is recessed in a concave configurationrelative to the outer peripheral rim such that the outer peripheral rimis a maxima of the activation surface.

Ectopic refers to the placement of a penile prosthetic deflationassembly between fascia and an exterior surface of a pelvis of thepatient.

Embodiments provide a penile prosthetic having a deflation assembly thatis easily identifiable to allow the patient to locate and activate(i.e., palpate) the deflation assembly. The deflation assembly isprovided separately from the reservoir and separately from the pump toallow the functional aspects of the pump and the deflation assembly tobe decoupled. This permits the pump to be manufactured in a smaller thanusual and allows the deflation assembly to be customized based onpatient anatomy.

A penile prosthetic deflation assembly is usually implanted in a scrotumof the patient, where the thin skin of the scrotum allows for easypalpation of the deflation assembly. However, some patients do not havethe dexterity to operate a deflation assembly that is implanted in thescrotum.

Some penile prosthetic devices include a deflation assembly incorporatedwith the pump. The pump is typically implanted in the scrotum of thepatient. It has been observed that the pump can rotate after it isimplanted. It is difficult for the user to locate the deflationmechanism incorporated into the pump if the pump rotates. Embodimentsprovide a deflation mechanism that is separate from the pump where thedeflation mechanism includes a prominent and easily identifiableactivation surface that is even identifiable through the skin and fattissue layers of clinically obese users.

FIG. 1 is a perspective view of one embodiment of an assembled penileprosthetic 20. The penile prosthetic 20 includes a penile implant 22, areservoir 24, a pump 26, and a deflation assembly 28. Each of the twoillustrated penile implants 22 provides a “cylinder” that is implantedin a corpora cavernosum within the shaft of the penis. The reservoir 24retains a fluid that is employed to inflate the penile implant 22. Thepump 26 is connected between the penile implant 22 and the reservoir 24and operates to move the fluid from the reservoir 24 to the penileimplant 22 to inflate the penile implant 22 to an erect state. Thedeflation assembly 28 functions to selectively restrict movement of thefluid from the penile implant 22 to the reservoir 24 to ensure that thepenile implant 22 remains erect when inflated. In addition, thedeflation assembly 28 functions to selectively move the fluid from thepenile implant 22 back to the reservoir 24 to deflate the penile implant22 to a flaccid state. The deflation assembly 28 provides a prominentactivation surface (described below) that is easily palpated by theuser.

In one embodiment, the penile implant 22 includes a pair of inflatablecylinders 32 that are sized to be implanted into the penis, and each ofthe cylinders 32 is connected to the pump 26 by tubes 34. The tubes 34are preferably kink-resistant. Each of the cylinders 32 includes aproximal end 36 opposite a distal end 38. During implantation, theproximal end 36 (also called a rear tip) is implanted toward the crus ofthe penis and the distal end 38 is implanted within the glans penis. Thecylinders 32 are fabricated from material configured to collapse and beflexible when the cylinders 32 are deflated to provide the penis with acomfortable flaccid state and expand when the cylinders 32 are inflatedwith liquid to provide the penis with an erection. Suitable material forfabricating the cylinders 32 includes silicone, polymers such asurethanes, blends of polymers with urethane, or copolymers of urethane,or the like. Suitable cylinders are available from Coloplast Corp.,Minneapolis, Minn.

The reservoir 24 is sized to hold a volume of liquid between about50-350 ml and is connected to the deflation assembly 28 by a tube 44.The tube 44 is preferably kink-resistant. In one embodiment, thereservoir 24 is provided as a cylindrical reservoir formed from anelastic, flexible polymer with a wall thickness of between 0.005-0.060inches. In one embodiment, the reservoir 24 is provided as a“cloverleaf” style of reservoir having multiple leaves that may befolded one against the other to compactly fold the reservoir 24 forimplantation into the abdomen of the user. The reservoir 24 isfabricated from material suitable for body implantation, such assilicone or the urethane-based materials described above for thecylinders 32. One suitable reservoir 24 is sized to containapproximately 130 ml of liquid and is available from Coloplast Corp.,Minneapolis, Minn.

The pump 26 generally includes a bulb or other mechanism provided tomove the fluid in the reservoir 24 to the penile implant 22. The pump 26is provided with a pair of inflation ports 44 that connect with thecylinders 32 via the tubes 34 and can include one or more suitable valveassemblies configured to check or limit the flow of the fluid to thecylinders 32. The pump 26 is fabricated from material suitable for bodyimplantation, such as silicone or the urethane-based materials describedabove for the cylinders 32.

The deflation assembly 28 is separate from the reservoir 24 and separatefrom the pump 26 and is connected between the pump 26 and the reservoir24 by a tube 54. The tube 54 is preferably kink-resistant.

FIG. 2 is a perspective view, FIG. 3 is a side view, and FIG. 4 is anend view of one embodiment of the deflation assembly 28. The deflationassembly 28 includes a side surface 60 extending between a base 62 andactivation surface 64. In one embodiment, the side surface 60 includesan inlet port 66 that communicates with the reservoir 24 and an outletport 68 that communicates the penile implant 22 (FIG. 1). The activationsurface 64 includes an outer peripheral rim 70 surrounding an activationarea 72. The activation area 72 is recessed in a concave configurationrelative to the outer peripheral rim 70 such that the outer peripheralrim 70 defines a maxima of the activation surface 64 (best illustratedin FIGS. 3 and 4). The activation area 72 provides a pad 72 that iscentral to the activation surface 64. In one embodiment, the activationarea 72 (or pad 72) is entirely located between the outer peripheral rim70 and the base 62.

The rim 70 protects the activation area 72 from unintended activation.The rim 70 is configured to be hard or immovable and easily identifiableeven through skin and tissue. The rim 70 provides a landmark that oncelocated directs the user to the location of the pad 72. The rim 70 isthus easily palpatable, but pushing on the rim 70 will not activate thedeflation mechanism of the assembly 28. The pad 72 is movable andprotected by the rim 70, but the pad 72 is easy to push once the rim 70is located.

The activation area 72 is movable, and in one embodiment is fabricatedfrom a polymer that is configured to be more flexible than the outerperipheral rim 70. In one embodiment, the outer peripheral rim 70 isharder (i.e., has a higher durometer) than the activation area 72. Inone embodiment, the activation area 72 is movable and the outerperipheral rim 70 is immovable.

The deflation assembly 28 generally encloses a valve or some sort ofvalve assembly (FIG. 5) that is located between the inlet port 66 andthe outlet port 68. The valve is provided to selectively restrictmovement of the fluid from the penile implant 22 to the reservoir 24when the penile implant 22 is erect. The activation surface 64, and inparticular the activation area 72, is operable to displace the valve toallow movement of the fluid from the penile implant 22 back to thereservoir 24 to return the penile implant 22 to a flaccid state.

In one embodiment, the activation area 72 is movable toward the base 62to move a position of the valve. In one embodiment, the outer peripheralrim 70 is substantially immovable and provides a hard, easily palpatablesurface for access by the user.

In one embodiment, the base 62 is a lower surface and the activationsurface 64 is an upper surface of the deflation assembly 28. Theactivation surface 64 provides a length L and a width W, and the sidesurface 60 provides a height H. In one embodiment, the length L of theactivation surface 64 is larger than the height H of the side surface60. In one embodiment, the width W of the activation surface 64 islarger than the height H of the side surface 60. In one embodiment, thelength L and the width W of the activation surface 64 are each largerthan the height H a side surface 60.

FIG. 5 is a cross-sectional view of the deflation assembly 28. Thedeflation assembly 28 encloses a valve 80 that is disposed within a flowpath 82. The flow path 82 extends between the inlet port 66 and theoutlet port 68. In one embodiment, the valve 80 is a ball valve that isbiased to seat against a valve seat 84 by a spring 86.

With reference to FIG. 1, when the pump 26 is repeatedly squeezed itdraws fluid from the reservoir 24. The fluid drawn out of the reservoir24 displaces the valve 80 off of the valve seat 84 to allow the fluid toflow through the flow path 82 and out of the outlet port 68 to thepenile implant 22. When the suction provided by the pump 26 is reduced,for example between squeezes of the pump or when the penile implant 22is inflated, the spring 86 forces the valve 80 against the valve seat 84and restricts movement of the fluid from the penile implant 22 back tothe reservoir 24. In one embodiment, the activation area 72 is movableand when pressed operates to displace the valve 80 off of the valve seat84 to allow the fluid in the penile implant 22 to return to thereservoir 24, which deflates penile implant 22.

In one embodiment, the deflation assembly 28 is fabricated from polymerand integrally surrounds the valve 80, the spring 86, and the flow path82. In one embodiment, the deflation assembly 28 is molded from siliconeas a monolithic and integral unit that encloses the valve 80.

In one embodiment, the activation area 72 is provided as a diaphragmflap that extends from the rim 70, and the diaphragm flap is movable todisplace the valve 80 away from the seat 84 to allow fluid to passthrough the flow path 82.

FIG. 6 is a schematic view of one embodiment of the penile prosthetic 20implanted in a man.

The cylinders 32 are each implanted into one of adjacent corporacavernosum of the penis with the proximal end 36 implanted into the crusof the penis and the distal end 38 implanted into the glans penis. Thereservoir 24 is implanted in the abdomen, either in front of or behindthe pubic bone based on the surgeon's preference. The pump 26 isimplanted in the scrotum. The deflation assembly 28 is connected betweenthe reservoir 24 and the pump 26 and is implanted under the skin infront of (i.e., exterior to) the pelvis. Suitable locations forimplantation of the deflation assembly 28 include between thetransversalis fascia and an exterior surface of the pelvis, or behindthe puborectalis muscle of the patient. Other suitable locations forimplantation of the deflation assembly 28 include placing the base 62 ofthe deflation assembly 28 against an iliac fossa of the pelvis, oragainst an iliac crest of the pelvis, or against the pelvis between ananterior gluteal line and an iliac crest of the pelvis.

During use, the pump 26 is repeatedly squeezed to draw fluid from thereservoir 24 through the deflation assembly 28 and into the cylinders 32implanted in the penis to move the penis from a flaccid state (solidlines) to an erect state (dotted lines). The valve 80 (FIG. 5) preventsthe fluid from leaving the cylinders 32 and moving back into thereservoir 24. The user presses on the activation area 72 of thedeflation assembly 28 to selectively transfer the fluid in the cylinders32 back to the reservoir 24 to move the penis from the erect state tothe flaccid state. In this regard, the deflation assembly 28 is placedbetween transversalis fascia and an exterior surface of a pelvis of thepatient and the outer peripheral rim 70 is configured to allow thepatient to easily feel and locate the activation area 72.

Other existing penile prosthetic devices associate the deflationassembly with the pump that is implanted and accessible in the scrotum,or with the reservoir that is implanted and accessible in the abdomen.However, the pump implanted in the scrotum can rotate over time orthrough use, which can make locating the deflation assembly difficult.Likewise, the reservoir implanted in the abdomen can move or shift,which makes locating the deflation assembly difficult. In addition, somepatients have additional skin folds or a layer of fatty tissue in theabdominal region, which can present challenges to the user in locatingthe deflation assembly. In contrast, the deflation assembly describedherein provides an activation surface having an outer peripheral rimthat defines a maxima of the activation surface, which makes thedeflation assembly easy to palpate (locate) and use. Specifically, theouter peripheral rim 70 is configured to allow a user to palpate throughthe skin and fatty tissues to locate the activation area.

Some penile prosthetic devices have a “low profile” reservoir that isdesigned to provide a minimal depth to reduce or eliminate thevisibility of the reservoir when it is implanted. For example, thisstyle of low profile reservoir allows the reservoir to be implanted infront of the puborectalis muscle and behind the abdominal fascia in alocation that is not noticeable from an external view of the patient. Ifsuch a reservoir would be modified to include a deflation assembly, thedeflation assembly would likewise be hidden from view and likelydifficult to locate/palpate/identify. In direct contrast, the deflationassembly described herein provides an activation surface having an outerperipheral rim that is easily identifiable when the deflation assemblyis placed between transversalis fascia and an exterior surface of apelvis of the patient.

FIG. 7 is a front view of a pelvis showing the deflation assembly 28implanted against an iliac fossa of the pelvis. The base 62 of thedeflation assembly 28 is placed against the iliac fossa with the tube 44extending to the reservoir 24 and the tube 54 extending to the pump 26.In this location, the deflation assembly 28 is located between thetransversalis fascia and an exterior surface of the pelvis. The base 62is thus placed against the hard surface of the iliac fossa and the outerperipheral rim 70 is easy to locate, which makes the activation area 72easily palpatable.

FIG. 8 is a side view of a pelvis showing the deflation assembly 28implanted against an iliac crest of the pelvis. The base 62 of thedeflation assembly 28 is located against the iliac crest with the tube44 extending to the reservoir 24 and the tube 54 extending to the pump26. In one embodiment, the base 62 of the deflation assembly 28 isplaced against the pelvis between an anterior gluteal line and an iliaccrest of the pelvis as illustrated. The base 62 is thus placed againstthe hard surface of the iliac crest and the outer peripheral rim 70 iseasy to locate, which makes the activation area 72 easily palpatable.

FIG. 9 is a top view of a pelvis showing the deflation assembly 28implanted between transversalis fascia and an exterior surface of thepelvis. In particular, the deflation assembly 28 is located against theiliac crest of the pelvis and behind the transversalis fascia.

In one embodiment, the deflation assembly 28 is implanted behind apuborectalis muscle of the patient.

Embodiments thus provide implantation of a deflation assembly such thatthe outer peripheral rim 70 is distal the pelvis.

FIG. 10A is a cross-sectional view of one embodiment of a penileprosthetic deflation assembly 100 and FIG. 10B is a cross-sectional viewof a valve assembly 102 of the deflation assembly 100. The deflationassembly 100 is operable with the kind of prosthetic described above,and is for example connected between the reservoir 24 and the pump 26(FIGS. 1 and 6) to operate the penile implant 22.

The deflation assembly 100 includes a side surface 110 extending betweena base 112 and activation surface 114. In one embodiment, the sidesurface 110 includes an inlet port 116 that communicates with thereservoir 24 and an outlet port 118 that communicates the penile implant22 (FIG. 1). The activation surface 114 includes an outer peripheral rim120 surrounding an activation area 122. The activation area 122 isrecessed in a concave configuration relative to the outer peripheral rim120 such that the outer peripheral rim 120 defines a maxima of theactivation surface 114.

In one embodiment, the deflation assembly 100 encloses a stem valve 130of the valve assembly 102 that is located between the inlet port 116 andthe outlet port 118. The stem valve 130 is provided to selectivelyrestrict movement of the fluid from the penile implant 22 to thereservoir 24 (FIG. 1) when the penile implant 22 is erect. Theactivation surface 114, and in particular the activation area 122, isoperable to displace the valve 130 to allow movement of the fluid fromthe penile implant 22 back to the reservoir 24 to return the penileimplant 22 to a flaccid state.

In one embodiment, the activation area 122 is movable toward the base112 to move a position of the valve 130. In one embodiment, the outerperipheral rim 120 is substantially immovable and provides a hard,easily palpatable surface accessible by the user.

FIG. 10B illustrates one embodiment in which the stem valve 130 isshaped as a prong that extends from the activation area 122 toward thebase 112 and is movable and so configured to displace an interface 140between the valve 130 and a flow path 142 in which the valve 130 isseated. In one embodiment, the stem valve 130 includes a spring 150 thatbiases a check valve 152 into engagement with the interface 140.

With additional reference to FIG. 1, repeated squeezing of the pump 26causes fluid to be drawn from the reservoir 24 through the inlet port116 (FIG. 10A), which displaces the check valve 152 and compresses thespring 150, to move the check valve 152 off of the interface 140 toallow the fluid to flow through the flow path 142, out of the outletport 118, and into to the implant 22.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

What is claimed is:
 1. A surgical method of treating erectiledysfunction, the method comprising: implanting a penile prosthetic in apatient, the penile prosthetic including an inflatable portionimplantable into a penis that is attachable to a liquid reservoir, apump, and a deflation assembly; implanting the inflatable portion intothe penis; implanting the liquid reservoir into the patient; implantingthe pump into the patient; implanting the deflation assembly in contactwith an exterior surface of a pelvis of the patient; and positioning anactivation surface of the deflation assembly away from the exteriorsurface of the pelvis thus allowing the patient to palpate theactivation surface through skin.
 2. The method of claim 1, furthercomprising positioning the activation surface of the deflation assemblyand allowing the patient to palpate the activation surface through fattytissue and skin.
 3. The method of claim 1, comprising implanting thepump into a scrotum of the patient.
 4. The method of claim 1, comprisingimplanting the reservoir in an abdomen of the patient.
 5. The method ofclaim 1, comprising implanting the deflation assembly betweentransversalis fascia and the exterior surface of the pelvis of thepatient.
 6. The method of claim 1, comprising implanting the deflationassembly behind a puborectalis muscle of the patient.
 7. The method ofclaim 1, comprising implanting a base of the deflation assembly againstan iliac fossa of the pelvis.
 8. The method of claim 1, comprisingimplanting a base of the deflation assembly against an iliac crest ofthe pelvis.
 9. The method of claim 1, comprising implanting a base ofthe deflation assembly against the pelvis between an anterior glutealline and an iliac crest of the pelvis.
 10. The method of claim 1,wherein the activation surface includes a maxima defined by an outerperipheral rim that surrounds an activation pad, the outer peripheralrim is rigid and the activation pad is recessed in a concaveconfiguration and movable relative to the rim.
 11. A method of treatingerectile dysfunction, the method comprising: implanting a penileprosthetic into a patient, the penile prosthetic including an inflatableportion and a deflation assembly, where the inflatable portion isimplantable into a penis and is inflatable by liquid stored in areservoir and is deflatable by activation of the deflation assembly;implanting the inflatable portion into the penis; implanting thereservoir into the patient; providing the deflation assembly with a baseopposite of a rim, with the rim surrounding a recessed activation pad;and implanting the base of the deflation assembly against an exteriorsurface of a pelvis of the patient.
 12. The method of claim 11,comprising implanting the deflation assembly between the exteriorsurface of the pelvis and transversalis fascia of the patient.